Questran Light

Primær information

  • Handelsnavn:
  • Questran Light 4 g pulver til oral suspension, enkeltdosisbeholder
  • Dosering:
  • 4 g
  • Lægemiddelform:
  • pulver til oral suspension, enkeltdosisbeholder
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

  • for den brede offentlighed:
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Lokation

  • Fås i:
  • Questran Light 4 g pulver til oral suspension, enkeltdosisbeholder
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 46738
  • Sidste ændring:
  • 01-02-2018

Produktresumé

26. maj 2015

PRODUKTRESUMÉ

for

Questran Light, pulver til oral suspension, enkeltdosisbeholder (Orifarm A/S)

0.

D.SP.NR.

2922

1.

LÆGEMIDLETS NAVN

Questran Light.

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

1 brev: Colestyramin 4 g som cholestyraminchlorid.

Alle hjælpestoffer er anført under pkt. 6.1.

3.

LÆGEMIDDELFORM

Pulver til oral suspension, enkeltdosisbeholder (Orifarm A/S).

4.

KLINISKE OPLYSNINGER

4.1

Terapeutiske indikationer

Hyperkolesterolæmi hvor diætbehandling har utilstrækkelig effekt.

Hudkløe ved partiel galdeobstruktion og galdesyre induceret diarré.

4.2

Dosering og indgivelsesmåde

Voksne:

1-2 breve (4-8 g) 3 gange daglig.

Questran Light må ikke tages tørt. Pulveret skal udrøres i vand eller anden væske inden

indtag. Pulveret kan desuden blandes i mad.

Da colestyramin kan binde anden medicin der administreres samtidig, skal patienten tage

anden medicin mindst 1 time før eller 4-6 timer efter Questran Light eller med så stort

interval som muligt, med henblik på at undgå at hæmme absorptionen (se pkt. 4.4).

46738_spc.doc

Side 1 af 7

Det foreslås at tage Questran Light i forbindelse med et måltid, men dette kan fraviges med

henblik på at undgå at hæmme absorption af anden medicin. Hvis det er nødvendigt at øge

dosis, skal dette foregå gradvist og med periodisk vurdering af lipid-/lipoprotein-niveauer.

Doser på mere end 24 g colestyramin daglig kan påvirke normal fedtabsorption (se pkt.

4.4).

Pædiatrisk population:

½ brev (2 g) 2 gange daglig, om nødvendigt stigende til voksendosis. For at minimere

eventuelle gastrointestinale bivirkninger anbefales det at påbegynde al behandling til børn

med en enkelt dosis Questran Light pr. dag. Dosis øges herefter gradvist hver 5.-7. dag

indtil effektiv kontrol er opnået.

Ældre

Der er ikke foretaget undersøgelser med ældre. Der kan ikke gives nogen anbefalinger

vedrørende dosering.

Nedsat nyre- og leverfunktion

Der er ikke foretaget undersøgelser med personer med nedsat nyre- eller leverfunktion. Der

kan ikke gives nogen anbefalinger vedrørende dosering.

4.3

Kontraindikationer

Total galdevejsobstruktion, hvor der ikke udskilles galde til tarmen.

Sivende eller blodig diaré.

Overfølsomhed over for colestyramin eller et eller flere af hjælpestofferne.

4.4

Særlige advarsler og forsigtighedsregler vedrørende brugen

Inden behandling med Questran Light påbegyndes, skal patienten undersøges og behandles

specifikt for sygdomme der kan medvirke til forhøjet blod-kolesterol, såsom

hypotyroidisme, diabetes mellitus, nefrotisk syndrom, dysproteinæmi og obstruktiv

leversygdom.

Inden behandling med Questran Light påbegyndes, skal serum-kolesterol også forsøges

kontrolleret ved passende diæt, vægtreduktion og behandling af eventuel underliggende

tilstand, som kan være årsag til hyperkolesterolæmien.

Tilfredsstillende kolesterolreduktion skal opnås i løbet af den første måned under

behandling med Questran Light, ellers bør ændring i behandlingen overvejes.

Colestyramin kan, da det udskiller galdesyre, påvirke normal fedtabsorption, når det gives i

høje doser (24 mg daglig). Når colestyramin gives i disse høje doser, kan det hæmme

absorption af de fedtopløselige vitaminer vitamin A, D, E og K. Når Questran Light

administreres i høje doser gennem længere tid, bør det derfor overvejes om patienten skal

tage tilskud af vitamin A, D, E og K.

Da absorption af fedtopløselige vitaminer kan mindskes ved biliær cirrhose, bør profylaktisk

behandling med supplement af A, D, E og K vitaminer overvejes til patienter med biliær

cirrhose.

Kronisk behandling med colestyramin kan være forbundet med øget blødningstendens på

grund af hypoprotrombinæmi forbundet med vitamin K-mangel. Dette vil sædvanligvis

46738_spc.doc

Side 2 af 7

straks respondere på parenteral administration af vitamin K. Recidiv kan forebygges ved

oral administration af vitamin K.

Der er set fald af folat i serum og i erytrocytter. I sådanne tilfælde bør behandling med

folinsyre overvejes.

Da præparatet er et kloridsalt af en basisk anionbytter, kan længerevarende brug af høje doser

medføre hyperchloræmisk acidose. Dette er særlig relevant hos yngre og mindre patienter,

hvor den relative dosis kan være højere.

Colestyramin kan medføre eller forværre allerede eksisterende obstipation eller forbundne

tilstande som f.eks. hæmorroider. Dosis af colestyramin bør nedsættes hos patienter med

obstipation, da der kan forekomme retention. Hos patienter med iskæmisk hjertesygdom,

hvor afføringsbelastning bør undgås, skal dosis af Questran Light titreres med henblik på at

undgå obstipation.

Hos patienter med diaré induceret af galdesyremalabsorption skal der ses respons inden for

3 dage. Hvis dette ikke er tilfældet, skal Questran seponeres, og anden behandling bør

overvejes.

Questran Light indeholder aspartam,en fenylalaninkilde, og kan være skadelig for patienter

med fenylketonuri (PKU, Føllings sygdom).

4.5

Interaktion med andre lægemidler og andre former for interaktion

Colestyramin kan forsinke eller reducere absorption af samtidig anden oral medicinsk

behandling, inklusiv orale antikoagulantia, doxepin, chlorthiazid, nikotinsyre, tetracyklin,

benzylpenicillin, phenobarbital, thyroideahormoner og digoxin.

Seponering af Questran Light kan udgøre en helbredsrisiko, hvis lægemidler med et

snævert terapeutisk vindue som f.eks. digoxin er blevet titreret til vedligeholdelsesniveau,

mens patienten tager Questran Light. Samtlige ovennævnte medicinske produkter skal

tages mindst 1 time før eller 4-6 timer efter colestyramin. Colestyramin kan også påvirke

lægemidler, som gennemgår hepatisk recirkulation (f.eks. østrogener).

4.6

Graviditet og amning

Graviditet:

Da colestyramin ikke absorberes systemisk, forventes det ikke at forårsage føtal skade ved

administration under graviditet, ved brug af anbefalede doser. Erfaringsgrundlaget for

anvendelse af Questran Light til gravide er dog ringe. Den kendte påvirkning af

absorptionen af fedtopløselige vitaminer, kan være uhensigtsmæssig selv ved tilskud af

vitaminer.

Amning:

Der bør udvises forsigtighed når colestyramin administreres til ammende kvinder. Den

potentielt påvirkede vitaminabsorption hos mødre beskrevet under "Graviditet" kan påvirke

ammede børn.

4.7

Virkning på evnen til at føre motorkøretøj eller betjene maskiner

Ingen mærkning.

46738_spc.doc

Side 3 af 7

4.8

Bivirkninger

Den mest almindelige bivirkning er obstipation. Hos ca 20-50% af patienterne kan

obstipation forekomme inden for de første dage efter behandlingsstart. Denne bivirkning er

dosisafhængig. Når Questran Light anvendes som kolesterolsænkende middel, er følgende

prædisponerende faktorer for de fleste af disse bivirkninger: Høj dosis og patientens alder

(patienter over 60 år). De fleste tilfælde af obstipation er milde, forbigående og kan

kontrolleres med konventionel behandling. Nogle patienter kan have behov for en

midlertidig reduktion i dosis eller seponering. Efter markedsføring er der rapporteret om

intestinal obstruktion med akkumulering af fæces, herunder 2 tilfælde af relaterede

dødsfald hos børn.

Bivirkninger er opstillet nedenfor efter organklassesystem og hyppighed med følgende

frekvenskategorier: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke

almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden

(<1/10.000), og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).

Metabolisme og ernæring

Ikke almindelig

Hypoprotrombinæmi på grund af nedsat

optag af vitamin K (ved længerevarende

behandling), A-vitaminmangel,

natteblindhed grundet A-vitaminmangel,

D-vitaminmangel, hyperchloræmisk

acidose, osteoporose, anoreksi

Ikke kendt

Fald i serum-folinsyre hos børn

Nervesystemet

Almindelig

Hovedpine

Ikke almindelig

Svimmelhed, paræstesi

Luftveje, thorax og

mediastinum

Ikke almindelig

Dyspnø

Mave-tarm-kanalen

Meget almindelig

Obstipation

Almindelig

Halsbrand, dyspepsi, flatulens, kvalme,

diarre, abdominalsmerter

Ikke almindelig

Opkastning, steatorré (ved høje doser),

dental caries, dysfagi, eructation,

gastrointestinal blødning,

hæmorideblødning, proctalgi, dysgeusi

Lever og galdeveje

Ikke almindelig

Abnorme levertal

Sjælden

Pankreatitis

Hud og subkutane væv

Ikke almindelig

Udslæt, irritation af hud og

slimhindeoverflader f.eks. tunge og

perianalområdet

Knogler, led, muskler og

bindevæv

Ikke almindelig

Artralgi, myalgi

Almene symptomer og

reaktioner på

administrationsstedet

Ikke almindelig

Overfølsomhedsreaktion, f.eks. urticaria

og ødem

Undersøgelser

Ikke almindelig

Vægtstigning

Indberetning af mistænkte bivirkninger

46738_spc.doc

Side 4 af 7

Når lægemidlet er godkendt, er indberetning af mistænkte bivirkninger vigtig. Det

muliggør løbende overvågning af benefit/risk-forholdet for lægemidlet. Læger og

sundhedspersonale anmodes om at indberette alle mistænkte bivirkninger via

Sundhedsstyrelsen

Axel Heides Gade 1

DK-2300 København S

Websted: www.meldenbivirkning.dk

E-mail: sst@sst.dk

4.9

Overdosering

Der er rapporteret om ét tilfælde med overdosering af Questran Light hos en patient, der tog

150% af maksimal anbefalet daglig dosis igennem flere uger. Der sås ingen bivirkninger.

Ved overdosering vil risiko for skadelig effekt primært være risiko forobstruktion af

gastrointestinalkanalen. Behandling vil afhænge af placeringen af en eventuel obstruktion,

graden af obstruktion og om tarmmotilitet er normal eller ej.

4.10

Udlevering

5.

FARMAKOLOGISKE EGENSKABER

5.0

Terapeutisk klassifikation

C 10 AC 01 – Galdesyrebindende midler, lipid-modificerende, usammesatte

5.1

Farmakodynamiske egenskaber

Colestyramin består af en stærk basisk anionbytter i kloridform og har en svag sur reaktion

(PH 5-6).

Colestyramin viser høj affinitet til galdesyre. Kloridionet i colestyraminstrukturen erstattes

med galdesyre, som dermed danner et uopløseligt kompleks og udskilles med fæces.

Reabsorption af galdesyrerne forhindres, og dette medfører et nedsat serumniveau af disse.

Tilførsel af colestyramin medfører et nedsat plasmaniveau af total kolesterol pga sænkning af

LDL (low density lipo-protein) fraktionen. Med et gennemsnitsindtag på 16 g colestyramin

per døgn, kombineret med let diæt har man set en sænkning af totalkolesterol og LDL-fraktio-

nen på 13% respektive 20%, som har resulteret i en 24% reduktion i dødsrisiko pga iskæmisk

hjertesygdom og en 19% risikoreduktion af ikke-fatalt hjerte infarkt. Plasmaniveauerne af

HDL (high density lipo-protein) øges med cirka 5%.

Plasmaniveauerne

triglycerider

øges

starten

sidenhen

returnere

udgangsværdierne. Udarbejdelse af patologisk arbejdstest og angina pectoris nedsættes med

25% respektive 20%.

Det antages, at kløe i forbindelse med partiel galdestase har sammenhæng med

overskudsdepoter af galdesyre i hudvæv. De normalt meget små mængder galdesyre i serum

kan gennem partiel galdestase 10-20 dobles og medføre alvorlig kløe. Ved at binde galdesyre

kan colestyramin lindre kløen. Et terapeutisk respons på behandlingen ses indenfor 1 måned

og vedvarer ved langtidsbehandling. Synergistik effekt opnås ved kombinationsbehandling

med statiner. Colestyramin kan også kombineres med nikotinsyre og fibrater.

46738_spc.doc

Side 5 af 7

5.2

Farmakokinetiske egenskaber

Absorberes ikke. Udskilles i fæces.

5.3

Prækliniske sikkerhedsdata

I dyreeksperimentelle studier (rotte) hvor colestyramin er brugt for at se hvordan fedt,

galdesalte og mikrobiel flora påvirker dannelse af intestinale tumorer via påvirkning af

potente

karsinogener

registreret

større

incidens

tumorer

colestyraminbehandlede rotter. Det er ikke kendt om disse laboratoriefund har nogen klinisk

relevans. I Lipid Research Clinics-Coronary Primary Prevention Trial var den totale mængde

af tumorer den samme i gruppen, som blev behandlet med diæt alene, som i den gruppe der

fik diæt plus colestyramin, medens forskellige former for kræft i mave- tarmkanalen var noget

hyppigere i colestyramingruppen. Materialet i de forskellige grupper er for småt til at drage

konkrete konklusioner.

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

Citronsyre, vandfri (E330); silica, kolloid; kelcoloid (E405); xanthangummi (E415);

appelsinsmagsstof; aspartam (E951).

6.2

Uforligeligheder

Ikke relevant.

6.3

Opbevaringstid

3 år.

6.4

Særlige opbevaringsforhold

Ingen.

6.5

Emballagetyper og pakningsstørrelser

Brev.

6.6

Regler for destruktion og anden håndtering

Ingen særlige forholdsregler.

7.

INDEHAVER AF MARKEDSFØRINGSTILLADELSEN

Orifarm A/S

Energivej 15

5260 Odense S

8.

MARKEDSFØRINGSTILLADELSESNUMMER

46738

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

17. juni 2010

10.

DATO FOR ÆNDRING AF TEKSTEN

26. maj 2015

46738_spc.doc

Side 6 af 7

46738_spc.doc

Side 7 af 7

  • Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.

    Anmode informationsbrochure for offentligheden.



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 2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

Enpr-EMA will hold its tenth annual workshop on 7-8 June 2018 at EMA. The workshop brings relevant stakeholders together to discuss requirements, barriers and opportunities for the conduct of high-quality clinical studies in children. The overall theme of this year’s workshop will be a ‘holistic approach to paediatric research’. Highlights of this year’s workshop include: i) short perspectives of the various stakeholders involved in paediatric research (patient/young people advisory groups, research netw...

Europe - EMA - European Medicines Agency

5-9-2018

In today’s FDA Voice Blog, I highlight our work to help address a potential road block to timely patient access to medical devices – payor coverage decisions. We want to be a partner in helping facilitate efficient access to beneficial innovations  https:

In today’s FDA Voice Blog, I highlight our work to help address a potential road block to timely patient access to medical devices – payor coverage decisions. We want to be a partner in helping facilitate efficient access to beneficial innovations https:

In today’s FDA Voice Blog, I highlight our work to help address a potential road block to timely patient access to medical devices – payor coverage decisions. We want to be a partner in helping facilitate efficient access to beneficial innovations https://go.usa.gov/xPcyB 

FDA - U.S. Food and Drug Administration

13-8-2018

More highlights from today's Pediatric Medical Device Development Public Meeting: Dr. Michelle Tarver of CDRH highlighting that collaboration is imperative in helping to promote pediatric device development. #devices4kids #MedicalDevicepic.twitter.com/mzl

More highlights from today's Pediatric Medical Device Development Public Meeting: Dr. Michelle Tarver of CDRH highlighting that collaboration is imperative in helping to promote pediatric device development. #devices4kids #MedicalDevicepic.twitter.com/mzl

More highlights from today's Pediatric Medical Device Development Public Meeting: Dr. Michelle Tarver of CDRH highlighting that collaboration is imperative in helping to promote pediatric device development. #devices4kids #MedicalDevice pic.twitter.com/mzlmU6Nq9U

FDA - U.S. Food and Drug Administration

13-8-2018

Highlights from today's Pediatric Medical Device Development Public Meeting: Bakul Patel discussed #digitalhealth and how technology enables development and access to safe medical devices #devices4kids #FDAPreCertpic.twitter.com/X4wQbX0Tjc

Highlights from today's Pediatric Medical Device Development Public Meeting: Bakul Patel discussed #digitalhealth and how technology enables development and access to safe medical devices #devices4kids #FDAPreCertpic.twitter.com/X4wQbX0Tjc

Highlights from today's Pediatric Medical Device Development Public Meeting: Bakul Patel discussed #digitalhealth and how technology enables development and access to safe medical devices #devices4kids #FDAPreCert pic.twitter.com/X4wQbX0Tjc

FDA - U.S. Food and Drug Administration

6-8-2018

Human medicines highlights - August 2018

Human medicines highlights - August 2018

This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency.

Europe - EMA - European Medicines Agency

31-7-2018

During the Pediatric Medical Device Development, public meeting, the #FDA will highlight pathways to encourage the development of medical devices for children. There is still time to register! Click the link to learn more.  https://go.usa.gov/xUvBD  #Pedi

During the Pediatric Medical Device Development, public meeting, the #FDA will highlight pathways to encourage the development of medical devices for children. There is still time to register! Click the link to learn more. https://go.usa.gov/xUvBD  #Pedi

During the Pediatric Medical Device Development, public meeting, the #FDA will highlight pathways to encourage the development of medical devices for children. There is still time to register! Click the link to learn more. https://go.usa.gov/xUvBD  #Pediatrics #medicaldevice pic.twitter.com/UzKDyAyER5

FDA - U.S. Food and Drug Administration

10-7-2018

Human medicines highlights - July 2018

Human medicines highlights - July 2018

This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency.

Europe - EMA - European Medicines Agency

8-5-2018

Human medicines highlights - June 2018

Human medicines highlights - June 2018

This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency.

Europe - EMA - European Medicines Agency

9-4-2018

Human medicines highlights - April 2018

Human medicines highlights - April 2018

This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency.

Europe - EMA - European Medicines Agency

9-3-2018

Human medicines highlights - March 2018

Human medicines highlights - March 2018

This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency.

Europe - EMA - European Medicines Agency

8-2-2018

Human medicines highlights - February 2018

Human medicines highlights - February 2018

This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency.

Europe - EMA - European Medicines Agency

5-1-2018

Human medicines highlights - January 2018

Human medicines highlights - January 2018

This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency.

Europe - EMA - European Medicines Agency

6-12-2017

Human medicines highlights - December 2017

Human medicines highlights - December 2017

This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency.

Europe - EMA - European Medicines Agency

8-11-2017

Human medicines highlights - November 2017

Human medicines highlights - November 2017

This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency.

Europe - EMA - European Medicines Agency